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Laryngeal Mask Supreme™ Versus the I-gel™

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00653237
First Posted: April 4, 2008
Last Update Posted: March 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
  Purpose
We evaluate two new developed airway devices, which provide patent airway during general anesthesia. In 60 patients undergoing elective general anesthesia, we will simulate a difficult airway by using an extrication device collar). We then place consecutively both airway devices in the mouth and check for ease of insertion and time used.

Condition Intervention
Patients Undergoing Elective General Anesthesia Device: I-gel and LMA Supreme: supraglottic airway devices

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Comparison of The Laryngeal Mask Supreme™ and the I-gel™ in a Simulated Difficult Airway Scenario in Anesthetized and Ventilated Patients

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • first attempt success rate and time to success [ Time Frame: during intervention ]

Secondary Outcome Measures:
  • leak pressure [ Time Frame: during intervention ]

Enrollment: 60
Study Start Date: March 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
crossover trial. insertion of both devices consecutively, computer randomized order
Device: I-gel and LMA Supreme: supraglottic airway devices
Insertion of a supraglottic airway device
Other Name: Laryngeal Mask Supreme, supraglottic airway device

Detailed Description:
The LMA Supreme™ and the I-gel™ are both new developed supraglottic airway devices to provide patent airways during general anesthesia. So far, prospective randomized controlled trials comparing their performance are not yet published. Both devices can be used in difficult airway situations, pre-hospital and in the hospital. In this prospective, randomized, controlled cross-over trial, we are going to evaluate the performance of both devices in a simulated difficult airway scenario using an extrication collar to limit both mouth opening and neck movement. In a maximum total of 60 patients undergoing elective surgery, we will place both airway devices consecutively and ventilate the patients. First attempt success rate and time to success will be recorded. Secondary outcomes include oropharyngeal pressure leak, ease of gastric catheter insertion, adverse events and side effects. Our hypothesis is that no difference exists between the two devices. Our 0-hypothesis is that there is a difference
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ASA 1-3 patients undergoing elective operation

Exclusion Criteria:

  • Not speaking german or refusing to participate
  • BMI >35, <50kg
  • Planned operation time >4h
  • High risk of aspiration
  • Cervical spine disease, known difficult airway, mouth opening <20mm
  • Upper respiratory tract symptoms in the previous 10 days
  • Preoperative sore throat
  • Poor dentition with high risk of damage
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653237


Locations
Switzerland
University Hospital
Berne, Switzerland, CH-3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Study Director: Robert Greif, M.D. Department of Anesthesia, University Hospital Berne, Switzerland
  More Information

Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT00653237     History of Changes
Other Study ID Numbers: igellma-1
First Submitted: April 1, 2008
First Posted: April 4, 2008
Last Update Posted: March 12, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Chlorhexidine
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants